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Efficacy and Safety of Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease: a Multicenter Randomized Controlled Trial
A prospective multicenter randomized controlled trial was conducted to evaluate the efficacy and safety of thoracoscopic biopsy guided by confocal optical real-time microscopic imaging (nCLE) in the diagnosis of fibrinal pleurisy of unknown etiology. Patients with fibrinous pleurisy of unknown etiology who were to undergo thoracoscopic pleural biopsy were enrolled and informed consent was signed. Subjects were randomized to either the nCLE guided biopsy Group (Group A) or the visual biopsy group (Group B) according to the randomization table (1:1 ratio). nCLE was used to probe the benign and malignant status of pleural lesions, compare the consistency of random pathological biopsy or nCLE guided biopsy with histopathological results, compare whether nCLE guided biopsy can reduce the number of thoracoscopic biopsies, and follow up short-term postoperative complications to evaluate its safety.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
January 1, 2025
Primary Completion Date
December 31, 2026
Completion Date
December 31, 2026
Last Updated
December 19, 2024
130
ESTIMATED participants
Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy
PROCEDURE
Plerual biopsy using medical thoracoscopy
PROCEDURE
Lead Sponsor
China-Japan Friendship Hospital
NCT07186933
NCT06686251
Data Source & Attribution
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